TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BAXTER HEALTHCARE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ELCAM MEDICAL ACAL
	SUBSTANTIALLY EQUIVALENT	2
M/S ROMSONS INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1
MONUMEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
YOMURA TECHNOLOGIES INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	998	1012
Leak/Splash	487	487
Disconnection	238	240
Crack	169	169
No Flow	145	145
Device Contamination with Chemical or Other Material	121	121
Break	117	117
Air/Gas in Device	90	90
Material Separation	82	82
Loose or Intermittent Connection	59	59
Particulates	51	51
Infusion or Flow Problem	49	49
Connection Problem	48	48
Detachment of Device or Device Component	46	46
Backflow	34	34
Separation Problem	24	24
Defective Component	24	24
Obstruction of Flow	20	20
Fitting Problem	14	14
Difficult to Open or Close	14	14
Packaging Problem	14	14
Gas/Air Leak	13	13
Complete Blockage	13	13
Physical Resistance/Sticking	12	12
Material Twisted/Bent	12	12
Fracture	12	12
Contamination	12	12
Free or Unrestricted Flow	12	12
Material Split, Cut or Torn	10	10
Excess Flow or Over-Infusion	10	10
Device Markings/Labelling Problem	8	8
Separation Failure	8	8
Defective Device	8	8
Delivered as Unsterile Product	7	7
Inaccurate Delivery	7	7
Material Puncture/Hole	7	7
Incomplete or Inadequate Connection	7	7
Mechanical Problem	7	7
Contamination /Decontamination Problem	6	6
Material Deformation	6	6
Unsealed Device Packaging	5	5
Improper Flow or Infusion	5	5
Inaccurate Flow Rate	5	5
Failure to Deliver	4	4
Retraction Problem	4	4
Flushing Problem	4	4
Failure to Prime	4	4
Material Protrusion/Extrusion	3	3
Material Integrity Problem	3	3
Microbial Contamination of Device	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1624	1624
No Consequences Or Impact To Patient	326	336
No Known Impact Or Consequence To Patient	253	257
Chemical Exposure	126	126
Insufficient Information	88	88
Low Blood Pressure/ Hypotension	72	72
No Patient Involvement	71	71
No Information	31	31
Hemorrhage/Bleeding	27	27
Blood Loss	19	19
Air Embolism	8	8
High Blood Pressure/ Hypertension	8	8
Low Oxygen Saturation	6	6
Hypoglycemia	5	5
Awareness during Anaesthesia	5	5
Death	5	5
Sepsis	5	5
Cardiac Arrest	5	5
Tachycardia	4	4
Nausea	3	3
Exposure to Body Fluids	3	3
Underdose	2	2
Headache	2	2
Discomfort	2	2
Loss of consciousness	2	2
Burning Sensation	2	2
Malaise	2	2
Missed Dose	2	2
Emotional Changes	2	2
Stroke/CVA	2	2
Skin Burning Sensation	2	2
Infiltration into Tissue	1	1
Bacterial Infection	1	1
Inadequate Pain Relief	1	1
Extubate	1	1
Irritability	1	1
Ventilator Dependent	1	1
Respiratory Failure	1	1
Tissue Damage	1	1
Hypoxia	1	1
Radiation Overdose	1	1
Pulmonary Embolism	1	1
Unintended Radiation Exposure	1	1
Increased Respiratory Rate	1	1
Laceration(s)	1	1
Hyperglycemia	1	1
Cardiopulmonary Arrest	1	1
Cardiogenic Shock	1	1
Erythema	1	1
Thrombosis/Thrombus	1	1